NCT04723381

Brief Summary

The aim of this study is to determine the effect of web-based genital hygiene education provided to orthopedically disabled women on self care agency and genital hygiene behaviors.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
62

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Dec 2018

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2018

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2019

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 10, 2020

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

January 19, 2021

Completed
6 days until next milestone

First Posted

Study publicly available on registry

January 25, 2021

Completed
Last Updated

January 28, 2021

Status Verified

January 1, 2021

Enrollment Period

1 year

First QC Date

January 19, 2021

Last Update Submit

January 25, 2021

Conditions

Disability PhysicalGenital Infection

Keywords

web based educationdisabled womengenital hygieneself care agency

Outcome Measures

Primary Outcomes (3)

  • Introductory Questionnaire

    The introductory questionnaire created for descriptive expressions

    Baseline

  • Change from the Baseline Self-Care Agency Scale Points at 7th and 15th weeks

    Self-Care Agency Scale was used to determine the self-care skills and abilities of the participants. It is a 5-point Likert-type scale with 35 items. Each item of the scale is scored between 0 and 4 (0= very uncharacteristic of me, 4= very characteristic of me). In the scale, 8 items (3, 6, 9, 13, 19, 22, 26, and 31) are scored reversely (0= very characteristic of me, 4= very uncharacteristic of me). The scale is evaluated over 140 points. In evaluation, the score over 120 points is defined as high, the score between 82 and 120 points is defined as moderate, and the score below 82 points is defined as low.

    Baseline, at the end of the 7th week, at the end of the 15th week

  • Change from the Genital Hygiene Behavior Scale Points at 7th and 15th weeks

    The Genital Hygiene Behavior Scale was used to determine the genital hygiene behaviors of the participants.It is a 5-point Likert-type scale with 23 items consisting of three sub-dimensions. The sub-dimensions of the scale are "General Hygiene (the first 12 items)", "Menstrual Hygiene (items between 13 and 20), and "Abnormal Finding Awareness (items between 21 and 23 )". Participants rate each item from 1 to 5 according to their suitability (1 = strongly disagree, 5 = Strongly agree). In the scale, 5 items (7, 14, 19, 20, 23) are scored reversely (1 = strongly agree, 5 = Strongly disagree). The highest score that can be obtained from the scale is 115 and the lowest score is 23. High scores indicate positive genital hygiene behavior.

    Baseline, at the end of the 7th week, at the end of the 15th week

Study Arms (2)

Experimental

EXPERIMENTAL

Partivipants recieved web based genital hygiene education for seven week

Other: web based education

Control

NO INTERVENTION

No intervention was applied to the women in the control group

Interventions

web based educationOTHER

Expert support and consultancy were received for the design and preparation of the web page.

Experimental

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Being orthopedically handicapped
  • Being literate, being over the age of 18
  • Having access to the internet
  • Being able to use the internet/computer
  • Being able to maintain genital hygiene individually.

You may not qualify if:

  • The inability to use the internet
  • Not being a member of the website
  • Having mental retardation
  • Being dependent on someone else to maintain genital hygiene (bedridden, with spasticity)
  • No willing to complete the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Inonu University

Malatya, 44280, Turkey (Türkiye)

Location

Study Officials

  • Yurdagul Yagmur, Prof

    Inonu University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

January 19, 2021

First Posted

January 25, 2021

Study Start

December 1, 2018

Primary Completion

December 1, 2019

Study Completion

July 10, 2020

Last Updated

January 28, 2021

Record last verified: 2021-01

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)